Bioequivalence and Bioavailability Forum

Dear All,

Kindly find the brief summary of below mentioned results for one of the pilot studies conducted. n=16, 2 way 2 period 2 treatment single dose crossover.

Parameter     Ratios  CI 90_L  CI 90_U  Power   IS CV (%)
Ln(Cmax)      98.58   77.47   128.41    0.4194  43.13
Ln(AUC last)  93.86   82.05   110.32    0.8307  22.51
Ln(AUC INF)   89.75   72.47   111.56    0.5223  33.65

As per the literature the molecule does not have iscv above 30% and therefore we need to design our pivotal study accordingly.

Can you let us know your feedback on the below mentioned:

1. Can we proceed with the pivotal study by considering the above results of pilot study?
   
   
2. Cmax and AUC inf are showing ISCV above 30%. Therefore what could be the conclusion for same?
   
   
3. As per the ratios of test/reference, are their any evaluations required with respect to formulation.
   
   
4. There are 2 subjects data out of 14 in which the concentration data is quite anomalous and not matching with the rest of the 14 subjects data. Would this be the reason for higher ISCV of Cmax and AUC Inf?
   
   
5. If we go by considering the above results for pivotal, what could be the design and an approximate sample size?

Thanks & Regards,
unique_one.

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Edit: Category changed. [Helmut]